Post-PCI chest pain combined with anxiety and/or depression symptoms
Conditions
Interventions
Control group:Placebo
Sponsors
Guangdong Provincial Hospital of Chinese Medicine
Eligibility
Sex/Gender
All
Age
18 Years to 77 Years
Inclusion criteria
Inclusion criteria: 1. Within one year after coronary intervention, if there is non-ischemic chest pain with an attack frequency of more than twice per week. 2. In a state of depression and/or anxiety, meeting the diagnosis of mild to moderate depression and/or mild to moderate anxiety: PHQ-9 score (5-14 points, inclusive) and GAD-7 score (5-14 points, inclusive). 3. Patients aged between 18 and 77 years (inclusive), regardless of gender. 4. Not using traditional Chinese medicine or Chinese patent medicines with the same efficacy as the trial drug, and not adding or increasing the dosage of anti-anginal Western drugs (excluding nitroglycerin tablets) in the original standardized Western drug treatment for coronary heart disease. 5. The patient can independently complete the questionnaire, is willing to undergo follow-up and signs the informed consent form.
Exclusion criteria
Exclusion criteria: 1. Those who are allergic to Shugan Jieyu Capsules, or who have had an allergic reaction to the traditional Chinese medicines Hypericum perforatum and Codonopsis pilosula in the past 2. Severe uncontrolled respiratory, digestive, kidney, blood, infectious, immune, endocrine, bone and joint, or tumor diseases, and chest pain caused by these diseases, or diseases that may pose a serious risk to the patient and are expected to have a survival period of less than 12 months 3. Ischemic chest pain: (1) Still having severe stenosis lesions after previous coronary artery revascularization surgery (visual assessment of the left main coronary artery diameter stenosis = 50% or non-left main diameter stenosis = 70%); (2) Previously experienced severe ST segment depression during exercise test and still existed after PCI surgery; (3) Chest pain accompanied by obvious ST-T dynamic changes and/or elevated myocardial injury markers; (4) Persistent severe angina pectoris (CCS grade IV) 4. Refractory heart failure or cardiogenic shock, NYHA cardiac function grade III-IV 5. Those who are preparing to undergo CABG or PCI during the trial 6. Severe arrhythmias (such as rapid atrial fibrillation, ventricular tachycardia, high-degree atrioventricular conduction block, etc.) 7. Severe liver disease patients or those with liver dysfunction (ALT, AST or TBIL > 3 times the upper limit of the normal reference range); Severe renal dysfunction (eGFR less than 15 mL/min/1.73m^2); Uncontrolled severe hypertension (systolic pressure > 180 mmHg, diastolic pressure > 110 mmHg); Uncontrolled severe hyperglycemia (fasting venous or capillary blood glucose > 200 mg/dl or 11.1 mmol/L twice or more within one month before participating in this trial) 8. Patients with a history of schizophrenia, bipolar disorder, organic mental disorders, dementia, mania, anorexia, bulimia, or other types of mental disorders; Patients with severe depression, suicidal tendencies, or intentions to harm others; Women in the childbearing age, pregnant, or breastfeeding, or those with a fertility intention within the past 6 months 9. Patients who have taken anxiety and depression-related drugs within the past month before enrollment, or have undergone neurosurgery or electroconvulsive therapy within the past 3 months before enrollment 10. In addition to coronary heart disease, accompanied by other diagnosed physical diseases 11. Participated in another clinical study within 2 weeks before enrollment or have undergone random grouping for this study before enrollment 12. Women in the childbearing age, pregnant, or breastfeeding, or those with a fertility intention within the past 1 year 13. Patients judged by the researchers to be unsuitable to participate in this study
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Seattle Angina Scale Score; | — |
Secondary
| Measure | Time frame |
|---|---|
| Visual analogue score for chest pain;TCM symptom efficacy score;Hamilton Anxiety Scale score;Hamilton Depression Scale score;Blood test, urine test, serum biochemistry, and coagulation test;12-lead electrocardiogram; | — |
Countries
China
Contacts
Public ContactWeihui Lv
Guangdong Provincial Hospital of Chinese Medicine
Outcome results
None listed